SWOG-9451, Combination Chemo & RT For Patients With Stage III/Stage IV Cancer of the Hypopharynx or Tongue

OBJECTIVES: I. Determine the complete histologic response rate (which represents the rate of
organ preservation) to induction with cisplatin/fluorouracil followed by radiotherapy plus
cisplatin in patients with selected stage III/IV cancer of the hypopharynx or base of the
tongue. II. Evaluate the feasibility of accruing and treating patients with this regimen in
a multi-institutional setting. III. Determine the overall complete response rate in these
patients.

OUTLINE: This is a multicenter study. Patients are stratified according to center and tumor
site (hypopharynx vs base of tongue). Base of tongue stratum closed as of November 15, 1998.
Regimen A: Patients receive cisplatin IV over 90 minutes on days 1 and 22 and fluorouracil
IV over 120 minutes on days 1-5 and 22-26. Patients with measurable neck nodes discontinue
therapy if disease has progressed by day 22. All patients who achieve complete or partial
response at day 43 proceed to regimen B. All others proceed to resection followed by
radiotherapy (off study). Regimen B (begins within 3-4 weeks of start of second induction
course): Patients receive cisplatin IV over 90 minutes every 3 weeks for 3 courses.
Concurrently, patients receive radiotherapy 5 days a week for 5.6 weeks. Patients are
reassessed at 8-12 weeks after radiotherapy. Patients who are disease free are observed.
Other patients undergo surgical resection of nodes and/or primary tumor. Patients are
followed every 4-6 weeks for 1 year, every 2 months for 1 year, every 4 months for 2 years,
every 6 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: Up to 70 patients (35/tumor site) will be accrued for this study over 3.5
years.

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the
hypopharynx or base of the tongue that is newly diagnosed and considered resectable For
hypopharyngeal cancer, total laryngectomy would be required surgery Disease staged by
clinical exam, endoscopy, and CT or MRI Stage III that is T2-3 N0-1 M0 Stage IV that is
T2-3 N2-3 M0 Measurable or evaluable disease other than pleural effusion, ascites, or
disease documented by indirect evidence Closed to patients with cancer of the base of
tongue as of 11/15/1998

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0 or 1 Hematopoietic: WBC at
least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST or ALT no greater than 3
times normal Renal: Creatinine no greater than 2 times normal Creatinine clearance at
least 60 mL/min Magnesium normal (supplementation allowed) Other: Average hearing loss in
both ears no greater than 40 dB in 50-2,000 Hz range No second malignancy within 5 years
except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix
Stage I/II cancer (other than head/neck) in complete remission Not pregnant or nursing
Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy